*Mail me your updated resume on chandrashekhar.ku...@diverselynx.com <chandrashekhar.ku...@diverselynx.com>*
Hello , We are currently looking for “*Sr. Compliance Analyst” *and your profile appears to be a good match. Please find the Job description below and contact me at your earliest possible convenience. *Role: **Sr. Compliance Analyst* *Duration: **6+ Months* *Location: Irvine, CA* *Mandatory Technical / Functional Skills * *Job Title* Sr. Compliance Analyst *Relevant Experience * *(in Yrs)* 4 years in Quality Systems; 5 years of experience supporting FDA audits. *Technical/Functional Skills* ASQ CQA certification preferred. *Experience Required* Preferred Related Industry Experience: Pharmaceuticals or Medical Devices. Working Knowledge of 21 CFR Part 820, QSR, ISO 13485, , SOR 98-282 CMDR (Canada Medical Device Regulations, J-PAL (Japanese), MDD (European) requirements, and knowledge of Brazil GMP. Experience in Medical Device Industry. Ability to interpret and apply regulatory requirements and industry best practices. Critical thinker, detailed oriented, while overseeing multiple tasks for several project. Experienced Internal/External Auditor. Excellent Investigative skills such as analytical problem solving, fish bone, root cause analysis, etc. Excellent analytical skills and ability to develop new metrics. Prepare and present written correspondence, reports, and materials in a clear, correct and comprehensible manner. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Strong organizational, interpersonal and collaborative skills. Ability to deal with pressure and provide constructive feedback. Must be able to work as part of a team as well as independently. *Roles & Responsibilities* The Sr. Compliance Analyst is responsible for the establishment and maintenance of processes pertaining to regulatory compliance to ensure regulatory requirements for compliance. Hosts external audits and regulatory inspections of Company processes and facilities; conducts mock audits to assess inspection readiness; provides training on inspection readiness. Manage, coordinate, and document external and SI audits. Conduct internal audits to ensure compliance within the organization as assigned. Plan, execute and follow up on audit activities. Audit/Inspection Readiness: Supports Company efforts in the preparatory activities for external audits and regulatory inspections. Maintains audit readiness program and manages audit activities related to external audits and regulatory inspections for the Company. Supports teams and functions in activities following external audits and regulatory inspections, including reviewing and/or approving the responses to observations prior to submission to sponsors and regulatory agencies. Prepares and communicates periodic summary reports and metrics on external audits and regulatory inspections. Develops and updates relevant Standard Operating Procedures (SOPs), Work Instructions (WIs), tools and training materials, to continuously improve the processes utilized for managing external audits and regulatory inspections within the Company. Provides training to applicable functions on audit and inspection readiness. Conducts and/or supports mock inspections. Maintains accurate and timely documentation of external audit and regulatory inspection activities. Assists in achieving the Company’s goal of being inspection ready at all times. Internal Compliance Surveillance (ICS): Lead the ICS review process, including documentation of reviews, identification of trends, and communication of results to management. Develops and updates relevant Standard Operating Procedures (SOPs), Work Instructions (WIs), tools and training materials, to continuously improve the process for ICS. *Generic Managerial Skills* Ability to work independently and manage teams with cross-functional participation while managing timelines. Working knowledge of project management techniques like Six Sigma, CPM and a strong understanding of statistics preferred. *Education* Master’s Degree (Scientific Discipline or related Engineering) or 4-year college degree (Bachelor’s Degree) or Equivalent CQE (*Certified Quality Engineer* <http://asq.org/cert/quality-engineer>) and/or CQA (*Certified Quality Auditor) Certification* <http://asq.org/training/certified-quality-auditor-certification-preparation_CQAR.html> *Start date* (dd-mmm-yy) Immediate *Duration of assignment *(in Months) 10 months *Work Location *(State, City and Zip) Irvine, CA, USA Thanks and Regards, Chandrashekhar Kumar Technical Recruiter Diverse Lynx, LLC Phone: 732-452-1006 Extn 265 Fax: 732-452-0684 Email – chandrashekhar.ku...@diverselynx.com Skype- Chandrashekhar.kumar4 -- You received this message because you are subscribed to the Google Groups "Oracle Users" group. 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